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Implant BreakageNCT04718454

Retention and Wear Characteristic Assessment of OT Equator Smart Box Attachment

An observational study of Implant Breakage, run by Cairo University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture Read more about this study

Who is it for?
Any age
Conditions the study is for
Implant Breakage
What is being tested?
dental attachment
Type of treatment
Medical device
How many people
10 participants
Where
No sites listed yet
Study dates
1 Feb 2021to 1 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Child, Adult, Older adult

Study population: 10 mandibular edentolous casts

Who may be able to join

  • mandibular cast

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet.

Doaa A Heshmat, lecturer contact

01006455491

doaa.heshmat@dentistry.cu.edu.eg

About this study

Official title: Retention and Wear Characteristic Assessment of OT Equator Smart Box Attachment Versus Ball Attachment for Mandibular Two Implant Assisted Over Denture , In-vitro Study

This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture

Read the detailed description

Implant supported overdenture can provide better mastication force than complete denture but less than the normal teeth . Most of the patient reported that implant supported overdenture has many superior features over the conventional complete denture in stability and retention Key factors related to successful treatment with overdentures include the number, location, and distribution of implants and choice of abutment. While the use of parallel implants that are widely distributed is generally desirable for optimal treatment, patients often present with challenging anatomical features, insufficient bone volume in all dimensions, and/or critical anatomy that precludes ideal placement of dental implants. Some clinicians may consider the ideal placement of implants for overdentures as parallel to each other and perpendicular to the occlusal plane of the denture Anatomical features associated with mandibular or maxillary edentulous ridges can range from straight or rounded to irregular and sharp ridges, and variability in bone width may limit potential implant sites for overdentures. Factors such as narrow bone volume, the inferior alveolar nerve being anterior or superior positioned, extensive bony undercuts, the inferior portion of the maxillary sinus, proximity to high-risk vascular structures, or a patient's desire to avoid additional surgical procedures may prompt a clinician to angulate a dental implant, which could result in the positioning of implants in non-ideal configurations.

Excessive angulation, increased maintenance and wear of inserts, and difficulty maintaining hygiene. Increased angulation may result in greater challenges to inserting and removing the prosthesis, which can become difficult for patients who are older and/or have limited dexterity. This challenge also can make it hard for patients to properly clean the inside of the retentive portion of the stud-style abutment and may increase wear of the retentive inserts Resilient Ball attachment most commonly used Ball attachment the simplest of all stud attachments which widely used because it is practical, effective, relatively low cost, less technique sensitive, ease of handling, minimal chair side time requirements and their possible applications with both root and implant-supported prostheses so it is used with non-splinted implants in clinical studies, it has been shown that changes in the retention of the prostheses occurred frequently. Both decrease and considerable increase in retention occurred as a result of attachment abrasion and micro movements during the mastication process The ball attachments showed only a few minor, easy manageable complications. Four out of 36 attachments gave reason for treatment. Two matrices loosened out of the mandibular denture and had to be fastened by adding acrylic resin after 1 and 4 weeks of loading. One patrix part of the ball attachment unsettled after 2 days of loading and was refastened. One ball attachment matrix lost its retention capacity and had to be reactivated after a period of 2 weeks. All these complications occurred in subjects where the implants were not perfectly parallel to each other positioned in the mandible. The loading conditions of these attachments were therefore not as favorable as for more parallel inserted implants A lack of parallelism of the implants creates considerable wear of the rubber rings in a relatively short time span.

Rhein 83, Italy, also has developed Smart Box, which could be used with the OT Equator in patients of extreme divergencies among the implants. The Smart Box has an inner tilting mechanism that enables a passive insertion with divergent implants up to 50 degrees(159).

Being tested
dental attachment
Keywords
dental attachment, overdenture

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • dental attachmentDevice

    This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture

Study groups in NCT04718454
Study groupRoleWhat they receive
Equator attachmentImplant installation over epoxy resin model at the canine area on both sides following the surgical protocol of the implant placement,Equator Attachment fabrication is firmly screwed to the fixture on both sides at the canine region
Receives: Device: dental attachment
ball attachmentImplant installation over epoxy resin model at the canine area on both sides following the surgical protocol of the implant placement,ball Attachment fabrication is firmly screwed to the fixture on both sides at the canine region
Receives: Device: dental attachment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Retention

    Retention of OT equator smart box attachment versus ball attachment for mandibular two implant assisted over denture

    Measured: 6 month

Secondary outcomes (1)
  1. wear evaluation

    wear evaluation of OT equator smart box attachment versus ball attachment for

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2021
  2. Study start1 Feb 2021 (estimated)
  3. Primary completion1 Jul 2021 (estimated)
  4. Study completion1 Aug 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Other
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04718454
Sponsor's protocol ID
equator implant attachment
Status last verified
Jan 2021
First submitted
16 Jan 2021
Last updated
22 Jan 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ahmad R, Abu-Hassan MI, Chen J, Li Q, Swain MV. The Relationship of Mandibular Morphology with Residual Ridge Resorption Associated with Implant-Retained Overdentures. Int J Prosthodont. 2016 Nov/Dec;29(6):573-580. doi: 10.11607/ijp.4726.

    PubMed 27824977

Questions about this trial

What is this clinical trial studying?

An observational study of Implant Breakage, run by Cairo University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Doaa A Heshmat, lecturer (01006455491, doaa.heshmat@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04718454, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.

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